BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FLEX-LOOP FLEXIBLE EAR CORETTE

    K Number: K852039 · Decision Jun 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    33

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    Basic Information

    Device Name
    FLEX-LOOP FLEXIBLE EAR CORETTE
    K Number
    K852039
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Bionix Corp.
    Date Received
    May 9, 1985
    Decision Date
    June 11, 1985
    Product Code
    JYG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JYG Curette, Ear

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    Other Clearances by Bionix Corp.

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    K860606 RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM